(b)(4).Year of birth: (b)(6).Concomitant medical products: 00596801452 62038496 lps flex femoral component-option for cemented use only nitrogen hardened size d right.Unknown tibial tray.Report source: foreign country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the provided picture confirms the articular surface post fractured.Sem analysis determined that the post fracture was caused by overloading on the post, exacerbated by potential impingement of the femoral component on the bearing surface at the base of the post, creating a fracture.Primary operative notes do not indicate any intra-op complications.Patient notes state that patient had an injury (twisted trauma) which led to fracture of implant.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.It was reported that the patient twisted her leg and had injury but it is not sure what caused the injury.Hence, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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